Splanchnic ablation improves exercise capacity in large subset of patients with HFpEF
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Key takeaways:
- Splanchnic ablation could improve exercise capacity and pulmonary capillary wedge pressure in some patients with HF with preserved EF.
- Researchers identified specific subgroups that may derive the most benefit.
Researchers identified a subgroup of patients with HF with preserved ejection fraction and elevated pulmonary capillary wedge pressure that may benefit from splanchnic ablation for volume management.
The findings from a primary analysis of the REBALANCE-HF randomized trial were presented at the Heart Failure Society of America Annual Scientific Meeting.
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“The splanchnic bed, which consists of organs in the abdomen, is the body’s main blood volume reservoir, holding up to 40% of the body’s blood volume. Activation of the sympathetic nervous system recruits blood from the splanchnic bed into central circulation. In HFpEF patients, the sympathetic nervous system is always active, resulting in chronic constriction of the splanchnic organs while increasing fluid in the heart and lungs. This stresses the heart and contributes to heart failure symptoms,” Marat Fudim, MD, MHS, advanced heart failure specialist and cardiologist at Duke Cardiology Clinic, told Healio. “Splanchnic ablation for volume management uses unilateral radiofrequency to selectively ablate the greater splanchnic nerve. The goal of the procedure is to reduce sympathetic tone, enabling targeted venodilation of the splanchnic bed to normalize blood volume in the heart and lungs and prevent congestion.”
Data from the first-in-human REBALANCE-HF study, presented in 2020, evaluated use of a greater splanchnic nerve ablation system (Satera, Axon Therapies) in 11 patients with chronic HFpEF and elevated pulmonary capillary wedge pressure (mean age, 70 years; 73% women).
As Healio previously reported, endovascular ablation of the right greater splanchnic nerve improved quality of life and functional capacity in patients with HFpEF.
For the present study, Fudim and colleagues evaluated the safety of splanchnic ablation for volume management, tested procedure replicability at multiple sites and identified responder subgroups for future studies.
The trial included 90 patients with HFpEF and elevated pulmonary capillary wedge pressure, of whom 44 were randomly assigned to the intervention (mean age, 72 years; 55% women; 85% white) and 46 were assigned to a sham procedure (mean age, 71 years; 74% women; 91% white).
The average treatment time was 53 minutes and 98% of procedures were successful.
The primary and secondary safety outcomes at 1 and 12 months, respectively, were similar between patients who underwent splanchnic ablation for volume management and sham.
“There was no statistical difference in safety outcomes at 1 month between the treatment and the sham arm,” Fudim told Healio. “In both arms, there were complications including two cases of aspiration during anesthesia and two patients who experienced procedural pain, which was transient.”
Fudim reported lower work index pulmonary capillary wedge pressure (–9 mm Hg/W/kg; P = .3) and longer exercise duration (35 seconds; P = .1) in the treatment arm compared with the sham arm; however, the researchers observed no significant differences in change in pulmonary capillary wedge, right atrial or pulmonary artery pressures between the two groups.
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ), 6-minute walk test and N-terminal pro-B-type natriuretic peptide levels were also not significantly different between the splanchnic ablation and sham groups.
The sham arm, however, required approximately twofold more add-on therapies compared with the treatment arm and had more unscheduled hospital visits.
Responder subgroups identified in the REBALANCE-HF study included those with a rise in cardiac output during exercise and when going from supine to standing position; those not hindered by chronotropic insufficiency; and those not limited by advanced structural heart disease, according to the presentation.
These responders had significant improvement in work index pulmonary capillary wedge pressure (–18 mm Hg/W/kg; P = .02) and exercise duration (95 seconds; P = .02) at 1 month and improved KCCQ overall summary score (10 points; P = .1), 6-minute walk test (41 m; P = .1) and NT-proBNP levels (275 pg/mL; P = .04) at 12 months compared with the sham arm.
“This is promising data for a large subset of HFpEF patients. In the REBALANCE-HF trial, this cohort represented approximately 55% of all the patients,” Fudim told Healio. “We will need further studies to validate these findings but are encouraged that splanchnic ablation for volume management offers a novel and beneficial treatment for HFpEF patients, a historically complex population to treat.
“HFpEF is an incredibly complex condition due to the varied phenotypes of the patient population and there are limited treatment options today,” he said. “The favorable hemodynamics and improvements in clinical symptoms in the responder population are promising given the randomized blinded nature of the study. While we need more data to confirm these results, splanchnic ablation for volume management has the potential to become a front-line interventional option for these patients.”
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Fudim M, et al. Late breaking clinical trials. Presented at: The Heart Failure Society of America Annual Scientific Meeting; Oct. 6-9, 2023; Cleveland.
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